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NUVIGIL (ARMODAFINIL) TABLETS: CLINICAL PHARMACOLOGY

Mechanism of Action and Pharmacology

The precise mechanism(s) through which armodafinil (R-enantiomer) or modafinil (mixture of R- and S-enantiomers) promote wakefulness is unknown. Both armodafinil and modafinil have shown similar pharmacological properties in nonclinical animal and in vitro studies, to the extent tested.

At pharmacologically relevant concentrations, Armodafinil (Nuvigil) does not bind to or inhibit several receptors and enzymes potentially relevant for sleep/wake regulation, including those for dopamine, serotonin, adenosine, melatonin, galanin, melanocortin, orexin-1, orphanin, PACAP or benzodiazepines, or transporters for GABA, serotonin, norepinephrine, and choline or phosphodiesterase VI, COMT, GABA transaminase, and tyrosine hydroxylase. Modafinil does not inhibit the activity of MAO-B or phosphodiesterases II-IV.

Modafinil-induced wakefulness can be attenuated by the alpha1-adrenergic receptor antagonist, prazosin; however, modafinil is inactive in other in vitro assay systems known to be responsive to alpha-adrenergic agonists such as the rat vas deferens preparation.

Nuvigil (Armodafinil) is not a direct- or indirect-acting dopamine receptor agonist. However, in vitro, both armodafinil and modafinil bind to the dopamine transporter and inhibit dopamine reuptake. For modafinil, this activity has been associated in vivo with increased extracellular dopamine levels in some brain regions of animals. In genetically engineered mice lacking the dopamine transporter (DAT), modafinil lacked wake-promoting activity, suggesting that this activity was DAT-dependent. However, the wake-promoting effects of modafinil, unlike those of amphetamine, were not antagonized by the dopamine receptor antagonist haloperidol in rats. In addition, alpha-methyl-p-tyrosine, a dopamine synthesis inhibitor, blocks the action of amphetamine, but does not block locomotor activity induced by modafinil.

Armodafinil (Nuvigil) and modafinil have wake-promoting actions similar to sympathomimetic agents including amphetamine and methylphenidate, although their pharmacologic profile is not identical to that of the sympathomimetic amines. In addition to its wake-promoting effects and ability to increase locomotor activity in animals, modafinil produces psychoactive and euphoric effects, alterations in mood, perception, thinking, and feelings typical of other CNS stimulants in humans. Modafinil has reinforcing properties, as evidenced by its self-administration in monkeys previously trained to self-administer cocaine; modafinil was also partially discriminated as stimulant-like.

Based on nonclinical studies, two major metabolites, acid and sulfone, of modafinil or armodafinil, do not appear to contribute to the CNS-activating properties of the parent compounds.